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EC number: 203-770-8
CAS number: 463-04-7
The aim of the study was to evaluate the possible ocular corrosive or
severe irritating effects of the test item after administration on
enucleated chicken eyes.
The test item ISOAMYL NITRITE was applied, as supplied, at the dose of
30 μL, to 3 enucleated chicken eyes, during 10 seconds. Then the eyes
were rinsed twice with 10 mL of physiological saline. Three eyes were
treated in the same manner with a positive control and one eye with a
negative control. Damages by the test item were assessed by
determination of corneal swelling, opacity, and fluorescein retention at
30, 75, 120, 180 and 240 minutes post-dose.
The experimental protocol was established in accordance with the
O.E.C.D. Test Guideline No. 438 adopted 09 October 2017 and the test
method B.48 – Commission Regulation (EU) No. 1152/2010 dated 08 December
2010 (EU Journal L324) - ATP Council regulation No. 440/2008 of 30 May
2008 (E.U. Journal L142).
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0.7, corresponding to ICE class
- mean score of fluorescein retention: 3.0, corresponding to ICE class
- maximal mean corneal swelling: 8%, corresponding to ICE class II.
The combination of the three endpoints for the test ISOAMYL NITRITE was
1 x IV, 2 x II.
The combination of the three endpoints for the positive control, 5%
Benzalkonium chloride, was 3 x IV. Therefore, the positive control is
classified as “Corrosive/Severe Irritant”, as expected.
The combination of the three endpoints for the negative control,
physiological saline, was 3 x I. Therefore, the negative control is
classified as “No Category”, as expected.
In accordance with the Regulation (EC) No. 1272/2008, the results
obtained under these experimental conditions lead to the category “no
prediction can be made”, as defined by the OECD guideline No.438.
Therefore, the test item ISOAMYL NITRITE is not predicted as causing
serious eye damage (Category 1) or as not classified for eye
irritation/serious eye damage (No category) with the Isolated Chicken
Eye test method. Additional testing (in vitro and/or in vivo) are
required to establish a definitive classification.
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